13
Mar

We Hope to See You at the 2024 PDA Week

Visit with Lachman Consultants at Booth 635 PDA Week is a must-attend event for professionals in the biopharmaceutical and pharmaceutical industries. This year’s event is taking place from Monday, March 25th to Wednesday, March 27th in Long Beach, CA. As a leading forum for knowledge-sharing and networking, this year’s event promises to deliver insights into […]

Read More
05
Apr
Mailbox

New FDA Program for Mail Back Envelopes for Opioids – Good News or Bad News?

On Monday, the FDA announced a change to the REMS for opioids to include a requirement “to make prepaid mail‑back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”  As part of the new, revised REMS requirement, “all manufacturers of opioid analgesics used in outpatient settings are […]

Read More
23
Dec

Analytical Method Validation, Verification, or Qualification – What to use and when?

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

Read More
15
Dec

Devices to Head onto the Inspection Delay or Refusal Bandwagon

Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]

Read More
05
Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

Read More
01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

Read More
09
Aug

Have an Approved NDA or ANDA for a Contrast Agent or Other Similar Device? Better Read This!

In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]

Read More
02
Mar

Recent Advances in Solid Dispersion Technologies

José L. Toro, Director, Lachman Consultants, wrote a recent article for Contract Pharma about improving the bioavailability and therapeutic efficiency of poorly soluble drugs. Here is a brief excerpt from the article: “Over forty percent (40%) of new chemical entities (NCEs) that are being developed confront the challenge of being poorly soluble in water. These […]

Read More
08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

Read More
04
Aug

Webinar: Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies (August 11, 2020 @1:00-2:00 PM ET)

In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]

Read More
1 2